Combining ovarian tissue freezing with egg (oocyte) freezing versus egg freezing alone

Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone: an Observational Study in Oncology Patients

This research will test whether combining ovarian tissue freezing with egg freezing helps adult women with cancer preserve more fertility than egg freezing alone.

Quick facts

• Study type: Observational
• Enrollment: 127 (estimated)
• Ages: 18 Years to 46 Years
• Sex: Female
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bologna, Bologna)
• Trial ID: NCT07546123 on ClinicalTrials.gov

What this trial studies

This observational project will collect clinical data from two groups of adult oncology patients facing potentially gonadotoxic treatment: those who undergo ovarian tissue cryopreservation followed by oocyte cryopreservation, and those who undergo oocyte cryopreservation alone. Investigators will compare outcomes such as number of preserved follicles, number of mature oocytes retrieved, timing relative to cancer therapy, and recovery of ovarian endocrine function. Eligible participants are women aged 18–46 with BMI between 17.5 and 32 and oncological clearance, while patients positive for HBV, HCV, HIV, or Treponema pallidum or with hypersensitivity to stimulation drugs are excluded. The study is single-center and will use routine clinical and laboratory records at the treating hospital to characterize real-world differences between the approaches.

Who should consider this trial

Good fit: Adults aged 18–46 with an oncological diagnosis who are planning potentially gonadotoxic therapy, have BMI of 17.5–32, and have oncological clearance are ideal candidates.

Not a fit: Patients outside the age or BMI limits, those with active HBV/HCV/HIV or syphilis, those without oncological clearance, or those unable to undergo ovarian stimulation or surgery may not receive benefit.

Why it matters

Potential benefit: If successful, the combined approach could preserve more follicles and mature eggs, increasing the chances of future pregnancy and helping restore ovarian hormonal function.

How similar studies have performed: Oocyte cryopreservation is well-established and ovarian tissue cryopreservation has led to restored ovarian function and live births in prior reports, but combining both approaches has limited published data.

Eligibility criteria

Inclusion Criteria:

* Patient with oncological disease eligible for potentially gonadotoxic therapy
* BMI ≥ 17.5 kg/m² and ≤ 32 kg/m²
* Age ≥ 18 years and ≤ 46 years

Exclusion Criteria:

* Hypersensitivity to one or more of the active substances used during ovarian stimulation treatment
* Positive for HBV, HCV, HIV, or Treponema pallidum
* Lack of oncological clearance

Where this trial is running

Bologna, Bologna

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (RECRUITING)

Study contacts

• Study coordinator: Diego Raimondo, MD

Conditions: Oncological Disease, Fertility Preservation